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Blood Pressure Changes During Moderate Intensity Strength Training in Aortic Stent-graft Patients

NCT ID: NCT03424863

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-22

Study Completion Date

2018-08-31

Brief Summary

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Patients with an aortic stent graft are recommended to do muscle strengthening exercise as part of their rehabilitation. But, as excess blood pressure pose a risk to the integrity of the stent graft, high intensity muscle strengthening exercise may potentially be detrimental, and hence moderate intensity muscle strengthening is recommended. However, the blood pressure changes during moderate intensity strengthening exercises are unknown, and this study aims to quantify these among patients and compare them to those of healthy volunteers.

Purpose:

The purpose of this study is to investigate the increase in blood pressure during quadriceps muscle strength training in patients with aortic stent graft.

Methods:

Patients with aortic stent graft will be included. The participants are investigated once. During the investigation, the blood pressure increase during a single strength training exercise (leg press) is measured. The strength training exercise is done at 60% of maximal strength (moderate intensity) corresponding to 15 Repitition Maximum (RM) (a load that can be lifted exactly 15 times).

Detailed Description

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Conditions

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Aortic Stent Graft

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Aortic stent graft patients

Patients who have received an aortic stent graft who will perform one session of moderate intensity muscle strengthening during which blood pressure will be measured.

Group Type EXPERIMENTAL

Moderate Intensity Muscle Strengthening

Intervention Type OTHER

1 session of lower extremity muscle strengthening at moderate intensity (60% of estimated maximal muscle strength). The exercise is performed on one single day.

Healthy volunteers

Healthy volunteers in general good health with no history of heart disease who will perform one session of moderate intensity muscle strengthening during which blood pressure will be measured.

Group Type EXPERIMENTAL

Moderate Intensity Muscle Strengthening

Intervention Type OTHER

1 session of lower extremity muscle strengthening at moderate intensity (60% of estimated maximal muscle strength). The exercise is performed on one single day.

Interventions

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Moderate Intensity Muscle Strengthening

1 session of lower extremity muscle strengthening at moderate intensity (60% of estimated maximal muscle strength). The exercise is performed on one single day.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults (+18y) with aortic stent graft following aortic dissection or aneurism
* Minimum 8 weeks post surgery
* Strengthening exercise approved by treating cardiologist
* Able to perform the exercise


* Adults (+18y)
* In good health (self report)

Exclusion Criteria

* Lack of ability to read, speak or understand instructions in Danish or English
* Other unspecified heart disease


• Lack of ability to read, speak or understand instructions in Danish or English
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marius Henriksen

OTHER

Sponsor Role lead

Responsible Party

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Marius Henriksen

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christian Dall, PhD

Role: STUDY_CHAIR

Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark

Locations

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Bispebjerg Hospital, Department of Physical and Occupational Therapy

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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FYS014

Identifier Type: -

Identifier Source: org_study_id